Safety and Performance of TAVI of Venus MedTech Aortic Valve Prosthesis (Venus-A)
|ClinicalTrials.gov Identifier: NCT01683474|
Recruitment Status : Unknown
Verified January 2015 by Venus MedTech (HangZhou) Inc..
Recruitment status was: Recruiting
First Posted : September 11, 2012
Last Update Posted : January 6, 2015
- Evaluate the performance of Venus MedTech aortic valve prosthesis intervention by femoral artery
- Evaluate safety and clinical benefit of percutaneous implantation of the Venue MedTech aortic valve prosthesis.
- Continuous observe 12 months of safety and efficacy.
- Approximately 80 patients presenting with native aortic valve stenosis necessitating valve replacement which are considered unsuitable for Surgical Valve Replacement, with a high surgical risk, as attested to by both the surgeon and the cardiologist are recruited in the study.
- Safety and performance will be evaluated at discharge and at 30 days post procedure. Valve safety, performance and placement will be followed up at 6 and 12 months post-procedure.
|Condition or disease||Intervention/treatment||Phase|
|Aortic Valve Stenosis Aortic Valve Calcification||Device: Venus MedTech Aortic Valve Prosthesis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Evaluation of the Safety and Performance of Percutaneous Implantation of the Venus MedTech Aortic Valve Prosthesis for Patients Who Cannot Undergo Surgical Valve Replacement|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||February 2016|
|Estimated Study Completion Date :||April 2016|
Experimental: Venus A-Valve
single arm with intervention that percutaneous implantation of the Venus MedTech Aortic Valve Prosthesis
Device: Venus MedTech Aortic Valve Prosthesis
Percutaneous implantation of aortic valve of Venus-A
- All cause mortality and major stroke at 12 months post-procedure. [ Time Frame: 12 months post-procedure ]
- Valve performance and placement at 6 and 12 months post-procedure [ Time Frame: 6 and 12 months post-procedure ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01683474
|Contact: Runlin Gao, MD||88398866 ext email@example.com|
|Fu Wai Hospital, CAMS & PUMA||Recruiting|
|Beijing, Beijing, China, 100037|
|Contact: Runlin Gao, MD firstname.lastname@example.org|
|Principal Investigator: Runlin Gao, MD|
|Principal Investigator:||Ruilin Gao, MD||Fuwai Hospital|